Business System Analyst Resume Round Lake, IL - Hire IT People

SUMMARY

More than 7 years of experience in all aspects of product lifecycle management, packaging testing, validation and project management in food, medical devices and pharmaceutical industries.
Well versed in project management, change management, CAPAs and leading cross functional teams.

TECHNICAL SKILLS

SAP Certified QMS Change Coordinator cGMP/GDP & ISO 13485 Compliance
Product Lifecycle Management
Agile Scrum
Waterfall methodology SDLC
JDEdwards
ICH Module 3 FDA submissions
MS Office Suite, SharePoint admin
TrackWise 8
HPALM
FDA Notices and Audit support
FDA FURLS
SQL
Lean Six Sigma / Kaizen
510k remediation
UAT / Regression Testing
SAP ERP PP - PI/MM/FICO/SD/BW
Global AdPromo Labeling
Packaging and IT validation
Veeva Vault

PROFESSIONAL EXPERIENCE

Confidential, Round Lake, IL

Business System Analyst

Responsibilities:

Developed test cases and executed UAT / regression testing on EBM for the MES JDE-EBM integration project in Crystal Reports and HPALM following Agile Scrum methodology.
Designed business flows in MS Visio, created IQ/OQ/PQ validation protocols and new master data in xTAB following SDLC change control protocols to implement changes using TrackWise 8 and Veeva Vault following ISO 13485, 21 CFR 11, 21 CFR 210 and 21 CFR 211 regulations.
Provided in-person and Service Now technical support to manufacturing in initial performance qualification runs and during normal production of Flexbumin including equipment updates, raw and finished materials BOM updates and troubleshooting SQL script errors in EBM filling, packaging, sterilization and cleaning cycles.

Confidential

Regulatory Specialist

Responsibilities:

Created labeling requirement documents (LRS) and master content redlines (MCD) using TrackWise 8, Veeva Vault, DOORs and Nuance Power PDF Advanced for new and existing renal care and acute therapy combination medical device products after performing global labeling gap assessments following regulatory compliance requirements of agencies like FDA, CFIA, Japanese MHW, EU MDD/MDR, and ANVISA.
Created SharePoint sites for reviewing SOPs, LRS and MCD documents.

Confidential, Chicago, IL

Quality Regulatory Associate

Responsibilities:

Created product registration databases and distributer lists for legacy Cardinal products, Patient Recovery and Cordis in SharePoint and MS Teams to reduce company response time to 1 business day for regulatory and customer queries.
Supported LATAM product registration by providing apostilled DoCs, CoEs, CoAs, and CFGs to distributers.
Proofread 510k submissions for LATAM region before translation to Spanish.

Confidential, Abbott Park, IL

Regulatory Affairs Project Specialist

Responsibilities:

Managed import of IVDs and biologics from APAC, EMEA and LATAM by working in the ACE system to register FDA Affirmation of Compliances codes using FURLS and recommended use of CDC, USDA and EPA guidelines & permits following 21 CFR, GCP and GMP regulations for in-process manufacturing, finished, clinical, complaint and V&V products.
Approved export of IVDs and biologics to APAC, EMEA and LATAM by creating attestations, FDA declarations and health certificates for in-process manufacturing, finished, clinical, complaint and V&V products.
Managed project metrics for import, export and global product registrations to ensure on-time product launches, in-process manufacturing shipments, clinical trials and complaint investigations.
Created legal documents for registering products globally including DoCs, CoEs, CoAs, CFGs, distribution authorization letters, supplier agreement letters, certificates of quality manufacture and ISO certificates for third party compliance.
Resolved MDM issues to create multiple master project lists for the department using MS Project, Cognos and Excel, investigated regulatory compliance emerging issues for EU/US for import/export SOP updates, supported FDA Audits and resolved FDA Notices.
Created regulatory technical data in IRIS, FOCUS, SharePoint and remediated 510k labeling for new ARCHITECT and ALINITY product launches.
Performed validation and updates of IRIS and FOCUS databases after IT upgrades following waterfall methodology SDLC requirements.
Organized and filed regulatory files using RIMS following FDA compliance requirements for records.

We provide IT Staff Augmentation Services!

Business System Analyst Resume

Round Lake, IL

We'd love your feedback!

Resume Categories

Client Services

Job Seekers

Visa Sponsorship